F.D.A. Rejects, for Now, a Change in How Long Blood Can Be Kept

By LAWRENCE K. ALTMAN

Published: January 30, 1991

The Federal Food and Drug Administration has rejected a recommendation from one of its expert panels that could greatly reduce the amount of blood available through military and civilian blood banks.

The experts had recommended nearly halving the maximum period that blood can be stored. The action came in response to reports that a small number of people getting transfusions died from an unusual bacterial infection that developed only from blood stored more than three weeks.

The F.D.A. rejected the recommendation on procedural grounds but said it would put the issue up for discussion at the expert committee's meeting in a few months.

The committee recommended reducing the maximum blood storage time to 25 days from 42 days. While there are no precise data on how quickly donated blood is used, a survey of 10 blood banks found that 35 percent of transfused blood had been stored 22 days or more; 20 percent had been stored for four weeks or more. The data were reported by the Council of Community Blood Centers in Washington.

Although the F.D.A. usually follows recommendations made by its expert committees, Dr. Gerald Quinnan, an official of the Federal agency, said in an interview yesterday that the agency was directing the committee to reconsider. Why Some Are Alarmed

The committee first voted to reject a recommendation to shorten the refrigerated shelf life of blood products containing red cells to 25 days from 42 days. The next day the committee reversed itself. But Dr. Quinnan said the vote was procedurally incorrect because the issue was not on the agenda for the second day of the meeting, which was held earlier this month.

The committee's recommendation has alarmed many blood bank officials who predicted that the drastically shortened storage time would cause severe blood shortages among military and civilian patients.

In anticipation of heavy casualties in the Persian Gulf, the American military has been gathering blood supplies from civilian agencies for the first time since the Korean War.

Col. Anthony Polk of the Army, head of the armed services blood program office, said the experts' recommendation, if put into effect, could be a problem for the military even though it stores blood for no more than 35 days

Dr. Harold Kaplan, an official of the New York Blood Center, said shortening the 42-day limit would hit patients in New York hospitals particularly hard. Pre-surgery Blood Donations

About 15 million pints of blood are transfused each year in civilian hospitals, and an additional 300,000 pints are transfused in United States military hospitals.

The Council of Community Blood Centers said that shortening the storage time could also hamper efforts to have patients donate their own blood before surgery. Patients facing elective surgery are now able to donate up to six units of blood. But when blood is stored, toxins produced by the bacteria can build up, making the blood dangerous even if it is given back to the person who donated it.

The committee's vote was in response to reports of nine severe transfusion reactions since 1987. The reactions resulted from contamination of transfused blood with a bacterium, Yersinia entercolitica. Seven of the nine cases were fatal. It was not clear whether other cases might have gone undetected. The Role of Bacteria

The nine cases of Yersinia infection compare to the 14 cases of infection with the AIDS virus that have developed among recipients of blood transfusions since the F.D.A. required blood banks to test for the AIDS virus in 1985, according to data from the Centers for Disease Control in Atlanta.

Yersinia bacteria cause diarrhea and other intestinal upsets that are not life threatening, and the number of such cases is rising in the general population.

When the same microbe grows in blood, it can produce toxins that cause shock and death. Experts are not certain how the Yersinia bacteria get into the blood; presumably a very small number escape from the intestines to invade the blood.

Cases of Yersinia infections from transfusions have been rare; only six were reported worldwide until 1987.

The number of Yersinia bacteria apparently are so low that they would not be readily detected by standard microbiology tests, Dr. Kaplan said. Yersinia bacteria apparently cannot be detected until after 21 days, according to a report by the Council of Community Blood Centers. Options for Blood Centers

The expert committee rejected suggestions that donors be questioned about a recent history of intestinal upset because it would require disqualification of very large numbers of donors to prevent the reactions, the Council of Community Blood Centers said in a report of the meeting.

A crucial question being debated by the expert committee, F.D.A. officials and blood bank workers is whether shortening the shelf life will create administrative problems that will be more serious than the Yersinia infections.

Another question is whether blood stored longer than a period of, for example, 25 days might be treated differently than that stored for a shorter period.

Red blood cells have a natural life span of about 120 days. For many years, the maximum storage time of such cells was limited to 21 days. But in recent years the introduction of a solution called Adsol extended the maximum storage time to 42 days.